Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.

Time Frame

Weeks 48 and 96

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility [ Time Frame: Baseline and time of virologic failure (up to Week 96) ]